MAUDE Adverse Event Report: DENTSPLY VDW GMBH RECIPROC BLUE FILES, 6X; FILE, PULP CANAL, ENDODONTIC

Catalog Number V040252031025

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.Involved products that broke during use were not returned and cannot be analyzed.Moreover, no unused file is available for evaluation.Nothing unusual to report was found during dhrs review.Root causes are not identified.We will track this kind of event and monitor the trend.

Event Description

This report is for the 2nd device - 2 of 2.In this event it was reported that two reciproc blue files broke during use at same patient; broken parts not removed yet.Update to be requested.Outcome of the event is unknown as of this mdr evaluation.

Manufacturer Narrative

The two returned reciproc blue files r25 8/100 31mm 025 are both broken at the base of the active part (fatigue).No material defect was found during analysis of the rupture patterns.No unused file is available for evaluation.Nothing unusual to report was found during dhrs review (batches #1680546, #1682905 and #1685927).Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: RECIPROC BLUE FILES, 6X
• Type of Device: FILE, PULP CANAL, ENDODONTIC
• Manufacturer (Section D): DENTSPLY VDW GMBH; bayerwaldstrasse 15; munich, 81737 ; GM 81737
• Manufacturer (Section G): DENTSPLY VDW GMBH; bayerwaldstrasse 15; munich, 81737 ; GM 81737
• Manufacturer Contact: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 12727870
• MDR Text Key: 279292389
• Report Number: 9611053-2021-00352
• Device Sequence Number: 1
• Product Code: EKS
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V040252031025
• Device Lot Number: 349807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Sex: Male